A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations

NCT06835569 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 3263-001
• Study Type: interventional
• Target: 448
• Locations: 1 country
• Sites: 12

Brief Summary

The purpose of this study is to characterize the safety and tolerability of ALTA3263 in adults with advanced solid tumors with KRAS mutations.

Conditions

Cancer; CRC (Colorectal Cancer); Advanced Solid Tumors; NSCLC (Non-small Cell Lung Cancer); PDAC - Pancreatic Ductal Adenocarcinoma

Keywords

KRAS mutation; NSCLC; Non-small cell lung cancer; Colorectal cancer; Pancreatic ductal adenocarcinoma; Colorectal carcinoma; Pancreatic cancer; Pancreatic carcinoma; Solid tumors; KRAS; Mutation; Metastatic; Advanced unresectable; Neoplasms; Neoplasms by Site; Carcinoma; Non-small cell lung carcinoma; Non-small cell lung neoplasm; Pancreatic neoplasm; Lung neoplasm; Colorectal neoplasm; Colon neoplasm; Mutant KRAS; KRAS amplification

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  Number of participants that experience treatment-emergent adverse events (TEAEs).

  Up to 39 months

• Dose Limiting Toxicities

  Number of participants with Dose Limiting Toxicities (DLTs).

  21 days

Secondary Outcomes (8)

• Maximum Observed Plasma Concentration (Cmax)

  Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose

• Area Under Plasma Concentration Time Curve During the Dosing Interval (AUCt)

  Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose

• Terminal Half-Life (t1/2)

  Cycle 1 (each cycle is 21 days) Lead-in phase: Predose and up to 48 hours postdose

• Objective Response Rate (ORR)

  Up to 39 months

Study Arms (10)

ALTA3263 monotherapy

EXPERIMENTAL

ALTA3263 will be administered continuously at a protocol-defined dose based on cohort assignment

Drug: ALTA3263

ALTA3263 in combination with cetuximab

EXPERIMENTAL

ALTA3263 in combination with cetuximab will be administered continuously at a protocol-defined dose based on cohort assignment

Drug: ALTA3263; Drug: cetuximab

ALTA3263 in combination with mFOLFOX6 plus cetuximab

EXPERIMENTAL

ALTA3263 in combination with modified folinic acid (leucovorin), fluorouracil, and oxaliplatin (mFOLFOX6) and cetuximab will be administered continuously at a protocol-defined dose based on cohort assignment

Drug: ALTA3263; Drug: cetuximab; Drug: mFOLFOX6

ALTA3263 in combination with pembrolizumab

EXPERIMENTAL

ALTA3263 in combination with pembrolizumab will be administered continuously at a protocol-defined dose based on cohort assignment

Drug: ALTA3263; Drug: Pembrolizumab

ALTA3263 in combination with pembrolizumab plus chemotherapy

EXPERIMENTAL

ALTA3263 in combination with pembrolizumab, pemetrexed, and carboplatin/cisplatin will be administered continuously at a protocol-defined dose based on cohort assignment

Drug: ALTA3263; Drug: Pembrolizumab; Drug: Pemetrexed + Cisplatin /Carboplatin

ALTA3263 in combination with mFOLFIRINOX

EXPERIMENTAL

ALTA3263 in combination with modified folinic acid (leucovorin), fluorouracil, irinotecan, and oxaliplatin (mFOLFIRINOX) will be administered continuously at a protocol-defined dose based on cohort assignment

Drug: ALTA3263; Drug: mFOLFIRINOX

ALTA3263 in combination with mFOLFIRINOX plus cetuximab

EXPERIMENTAL

ALTA3263 in combination with modified folinic acid (leucovorin), fluorouracil, irinotecan, and oxaliplatin (mFOLFIRINOX) plus cetuximab will be administered continuously at a protocol-defined dose based on cohort assignment

Drug: ALTA3263; Drug: cetuximab; Drug: mFOLFIRINOX

ALTA3263 in combination with GnP

EXPERIMENTAL

ALTA3263 in combination with gemcitabine and albumin-bound paclitaxel will be administered continuously at a protocol-defined dose based on cohort assignment

Drug: ALTA3263; Drug: GnP

ALTA3263 in combination with GnP plus cetuximab

EXPERIMENTAL

ALTA3263 in combination with gemcitabine, albumin-bound paclitaxel plus cetuximab will be administered continuously at a protocol-defined dose based on cohort assignment

Drug: ALTA3263; Drug: cetuximab; Drug: GnP

ALTA3263 Midazolam DDI Substudy

EXPERIMENTAL

ALTA3263 and midazolam will be administered at a protocol defined schedule

Drug: ALTA3263; Drug: Midazolam

Interventions

mFOLFOX6 DRUG

modified folinic acid (leucovorin), fluorouracil, and oxaliplatin will be administered at a protocol-defined dose

ALTA3263 in combination with mFOLFOX6 plus cetuximab

GnP DRUG

gemcitabine and albumin-bound paclitaxel will be administered at a protocol-defined dose

ALTA3263 in combination with GnP; ALTA3263 in combination with GnP plus cetuximab

ALTA3263 DRUG

Oral ALTA3263 tablets will be administered at a protocol-defined dose

ALTA3263 Midazolam DDI Substudy; ALTA3263 in combination with GnP; ALTA3263 in combination with GnP plus cetuximab; ALTA3263 in combination with cetuximab; ALTA3263 in combination with mFOLFIRINOX; ALTA3263 in combination with mFOLFIRINOX plus cetuximab; ALTA3263 in combination with mFOLFOX6 plus cetuximab; ALTA3263 in combination with pembrolizumab; ALTA3263 in combination with pembrolizumab plus chemotherapy; ALTA3263 monotherapy

Pembrolizumab DRUG

Pembrolizumab injection for IV use will be administered at a protocol-defined dose

ALTA3263 in combination with pembrolizumab; ALTA3263 in combination with pembrolizumab plus chemotherapy

mFOLFIRINOX DRUG

modified folinic acid (leucovorin), fluorouracil, irinotecan, and oxaliplatin will be administered at a protocol-defined dose

ALTA3263 in combination with mFOLFIRINOX; ALTA3263 in combination with mFOLFIRINOX plus cetuximab

Midazolam DRUG

Oral midazolam will be administered at a protocol-defined dose

ALTA3263 Midazolam DDI Substudy

Pemetrexed + Cisplatin /Carboplatin DRUG

Pemetrexed and carboplatin/cisplatin injection for IV use will be administered at a protocol-defined dose

ALTA3263 in combination with pembrolizumab plus chemotherapy

cetuximab DRUG

Cetuximab injection for IV use will be administered at a protocol-defined dose

ALTA3263 in combination with GnP plus cetuximab; ALTA3263 in combination with cetuximab; ALTA3263 in combination with mFOLFIRINOX plus cetuximab; ALTA3263 in combination with mFOLFOX6 plus cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of a solid tumor malignancy harboring a KRAS mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic test.
• Unresectable or metastatic disease.
• Progressed on, intolerant to, or declined prior standard-of-care therapy (including targeted therapy, if applicable) appropriate to tumor type and stage
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate organ function

You may not qualify if:

• Prior treatment with a KRAS inhibitor, certain exceptions are described in the full study protocol
• Known condition that prohibits the ability to swallow or absorb an oral medication.

Sponsors & Collaborators

• Alterome Therapeutics, Inc.: lead

Study Sites (12)

Research Site

Orlando, Florida, 32827, United States

RECRUITING

Research Site

Boston, Massachusetts, 02114, United States

RECRUITING

Research Site

Boston, Massachusetts, 02115, United States

RECRUITING

Research Site

St Louis, Missouri, 63110, United States

RECRUITING

Research Site

New York, New York, 10016, United States

RECRUITING

Research Site

New York, New York, 10032, United States

RECRUITING

Research Site

Durham, North Carolina, 27710, United States

RECRUITING

Research Site

Nashville, Tennessee, 37203, United States

RECRUITING

Research Site

Houston, Texas, 77030, United States

RECRUITING

Research Site #2

San Antonio, Texas, 78229, United States

RECRUITING

Research Site

San Antonio, Texas, 78229, United States

RECRUITING

Research Site

Fairfax, Virginia, 22031, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Pancreatic Neoplasms; Neoplasm Metastasis; Neoplasms by Site; Carcinoma; Lung Neoplasms; Colonic Neoplasms

Interventions

Cetuximab; pembrolizumab; Pemetrexed; Cisplatin; Carboplatin; Midazolam

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Benzodiazepines; Benzazepines

Study Officials

• Study Medical Director

  Alterome Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Alterome Clinical Trial Contact Center

CONTACT

619-768-8189; clinical.trials@alterome.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 19, 2025
• Study Start: March 5, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)